MedEx Neotest Dengue Combo NS1 Ag and IgG/IgM Antibodies Test Kit Dosage/Direction for Use

Specimen Preparation: Blood samples may be collected by fingerstick or venipuncture, following routine facility procedures.
For whole blood samples, collect blood in a tube containing anticoagulant.
For serum samples, collect blood in a tube without anticoagulant and allow it to clot.
For plasma samples, collect blood in a tube containing anticoagulant.
Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear, non-hemolyzed specimens.
Whole blood samples should be tested immediately after sample collection.
The blood may be stored at 2°C to 8°C for up to three days if the tests cannot be performed immediately. Ensure that the blood samples should be allowed to attain room temperature prior to use.
Test Procedures: 1. Remove the testing device from the sealed pouch by tearing at the notch and place the testing device on a leveled surface.
2. Add samples (Whole blood or Serum/Plasma): Dengue IgG/IgM: Add samples with pipette to upper area (close to test window) of sample well of the test device according to following table. Hold the pipette vertically and gently touch the end against the pad within the sample well for transferring).
Dengue NS1: Hold the sample dropper vertically. Add the specimen without air bubbles into the Sample Well according to following table.
Add diluents: Immediately add 2 drops (90 µl) of diluents to the proper sample well of the testing device according to following table: (See table.)

Click on icon to see table/diagram/image

3. Read the results in 10-30 minutes. Read results as shown under interpretation of results.
NOTE: Strong positive specimens may produce positive result in as little as 1 minute and confirm negative results in 20-30 minutes.
Result Interpretations: NS1 Results: (See Figure 1.)

Click on icon to see table/diagram/image

Negative: A pink colored band appears only at the control region (C), indicating a negative result for Dengue virus infection.
Positive: A clear pink control band (C) and a detectable test band (NS1) appears, indicating a positive result for Dengue virus infections.
Invalid: No visible band appears at the control region (C). Repeat with a new test device. If the test still fails, please contact the distributor with the lot number.
IgG/IgM Results: (See Figure 2.)

Click on icon to see table/diagram/image

Negative: A pink colored band appears only at the control region (C), indicating a negative result for Dengue virus infection.
Positive: Pink colored bands appear at the control region (C) and IgM and/or region.
1) IgG and IgM Positive, visible bands indicating positive result for a possible a late primary or acute secondary infection.
2) IgM positive, a visible band at IgM region, indicating positive result for a possible primary dengue infection.
3) IgG positive, a visible band at IgG region, indicating a positive result for a possible secondary infection or past infection.
Invalid: No visible band appears at the control region (C). Repeat with a new test device. If the test still fails, contact the distributor with the lot number.
Quality Control: Although the testing device contains an internal quality control (pink colored band in the control region), good laboratory practice recommends the daily use of an outside control to ensure proper testing device performance. Quality control samples should be tested according to the standard quality control requirements established by the laboratory.
Limitation: Humidity and temperature can adversely affect results.
The instructions for the use of the test should be followed during testing procedures.
There is always a possibility that false results will occur due to the presence of interfering substances in the specimen or factors beyond the control of the manufacturer, such as technical or procedural errors associated with the testing.
Although the test demonstrates superior accuracy in detecting antibodies and antigens against the Dengue virus, a low incidence of false results can occur. Therefore, other clinically available tests are required in case of questionable results. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.